Voice-activated Intelligent Personal Assistant (VIPA) Intervention for People With Parkinson's Disease

Parkinson's Disease and Parkinsonism Clinical Trial

Official title:

Efficacy of the Voice-activated Intelligent Personal Assistant (VIPA) Intervention on Psychosocial Well-being Among People With Parkinson's Disease: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036771
• Other study ID #: HSEARS20221107005
• Status: Recruiting
• Phase: N/A
• Start date: August 6, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: Angela Leung, PhD
• Phone: +852 2766 5587
• Email: angela.ym.leung[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot randomized control trial (RCT) aims to develop a Voice-activated Intelligent Personal Assistance (VIPA) user protocol and study its feasibility and preliminary efficacy among 60 People with Parkinson's disease (PWP). The research questions are:

Phase 1:

1. What components should be included in the VIPA user protocol community-dwelling PWP?

2. Is it feasible to implement the VIPA intervention in the PD population?

3 focus group interviews and 3 cognitive interviews will be held to formulate the VIPA user protocol. 5 healthcare and information technology experts will be invited to rate the relevancy of the formulated protocol and the item content validity index will be calculated by the researcher.

Phase 2:

1. What is the preliminary efficacy of VIPA intervention on SOC and psychosocial well-being?

2. Can such effect sustain for 4 weeks?

3. What is the users' experience on the VIPA intervention?

60 participants will be randomized into the intervention group (IG) and control group (CG). During the 8-week intervention period, IG participants will receive the following materials:

1. User protocol

2. Designate VIPA

3. 30-minute VIPA training on day 1

4. Weekly technical support phone calls. CG participants will receive usual care, no intervention will be provided to CG participants, and they will continue their daily life during the intervention period.

The researcher will compare both groups to study the feasibility and preliminary efficacy of the VIPA on the participants' psychosocial well-being and sense of coherence.

Description:

Background:

Parkinson's disease (PD) is one of the two most common neurodegenerative diseases affecting millions worldwide. PD research generally focuses on motor functioning and calls for more psychosocial interventions for people with Parkinson's disease (PWP).

The proposed VIPA intervention is an artificial intelligent personal assistant commonly used within Western society but not Asian countries, facilitating users' daily living by performing audio calls, messaging, and information searching. Recent literature showed VIPA Implementation is promising for rehabilitation in older adults but warrants more interventional studies to examine its efficacy and if it applies to other illnesses. Therefore, this study will formulate a positive health-orientated VIPA intervention protocol and investigate its efficacy in promoting PWP's sense of coherence and psychosocial well-being.

Objectives of the study:

This is a 2-phase study, and the objectives are:

Phase 1:

1. To develop and validate the VIPA user protocol.

2. To examine the feasibility of the VIPA intervention.

Phase 2:

1. To investigate the preliminary efficacy of the VIPA intervention on PWP's SOC

2. To explore the users' experience of VIPA intervention among PWP.

Method:

Phase 1: 3 semi-structured focus group interviews will be held to generate items in user protocol. Another 3 cognitive interviews will be held with PWP to test the face validity and feasibility of the user protocol. 5 healthcare and information technology experts will then be invited to assess the content validity of the protocol. Any item with an item content validity index (i-CVI) score lower than 0.78 will be discarded or revised.

Phase 2: 60 participants will be randomized into the intervention group (IG) and control group (CG). During the 8-week intervention period, IG participants will receive the user protocol, a designated VIPA, a 30-minute VIPA training on day 1, and weekly technical support phone calls. CG participants will receive usual care (no intervention will be provided to CG participants), and they will continue their daily life during the intervention period. The 13-item Sense of Coherence Scale (SOC-13) will be set as the primary outcome, and secondary outcomes are: 1. University of California, Los Angeles (UCLA) three-item loneliness scale; 2. Parkinson's Disease Questionnaire (PDQ-8); 3. EuroQol-5 dimension-5 level; 4. Mental Health Continuum Short Form; 5. System Usability Scale; 6. Brief Resilient Coping Scale; 7. Montreal Cognitive Assessment; and 8. Self-report VIPA usage.

12 participants will then be selected through extreme case sampling to partake in explanatory, in-depth interviews based on their SOC-13 score differences between baseline and post-intervention tests to explore VIPA user experience.

Data analysis:

For qualitative data, content analysis will be used in phase 1, while in phase 2, in-depth interview data will be analyzed through deductive thematic analysis according to the salutogenic model. Quantitative data, such as demographic data, will be presented with descriptive statistics. Chi-square test and independent t-test will be performed for baseline comparison. Generalized Estimating Equations will be used to analyze group differences in all primary and secondary outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cantonese-speaking Hong Kong permanent resident

• Diagnosed with Parkinson's disease

• Level 1-4 in the H&Y scale (Hoehn & Yahr, 1967)

• Not currently using or owning VIPA

• Has stable Wi-Fi connection at home.

Exclusion Criteria:

• PWP or their caregivers that fails to provide valid consent

• Individuals with hearing loss in both ears

• Severe voice impairment

• Dementia patients (MoCA score <21)

• PWP will leave Hong Kong during the intervention period.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders

Intervention

Device:
• Voice-activated Intelligent Personal Assistant (VIPA)
Apple HomePod mini is selected as the intervention medium of this study as it is the only available smart speaker that supports Cantonese

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (11)

Antonovsky, A. (1987). Unravelling the mystery of health: How people manage stress

Arnold A, Kolody S, Comeau A, Miguel Cruz A. What does the literature say about the use of personal voice assistants in older adults? A scoping review. Disabil Rehabil Assist Technol. 2022 Apr 22:1-12. doi: 10.1080/17483107.2022.2065369. Online ahead of print. — View Citation

Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability evaluation in industry, 189(194), 4-7.

Cools CI, de Vries NM, Bloem BR. Happiness: A Novel Outcome in Parkinson Studies? J Parkinsons Dis. 2020;10(3):1261-1266. doi: 10.3233/JPD-201999. — View Citation

Jenkinson, C., Fitzpatrick, R., Peto, V., Greenhall, R., & Hyman, N. (1997). The PDQ-8: development and validation of a short-form Parkinson's disease questionnaire. Psychology and Health, 12(6), 805-814.

Keyes, C. L. (2018). Overview of The Mental Health Continuum Short Form (MHC-SF). doi: 10.13140/RG.2.2.24204.62088.

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

NIEHS(2021). Neurodegenerative Diseases. Retrieved from United States Department of Health and Human Services, The National Institute of Environmental Health Sciences (NIEHS) Web site: https://www.niehs.nih.gov/research/supported/health/neurodegenerative/index.cfm

Sinclair VG, Wallston KA. The development and psychometric evaluation of the Brief Resilient Coping Scale. Assessment. 2004 Mar;11(1):94-101. doi: 10.1177/1073191103258144. — View Citation

Subramanian I, Hinkle JT, Chaudhuri KR, Mari Z, Fernandez H, Pontone GM. Mind the gap: Inequalities in mental health care and lack of social support in Parkinson disease. Parkinsonism Relat Disord. 2021 Dec;93:97-102. doi: 10.1016/j.parkreldis.2021.11.015. Epub 2021 Nov 27. — View Citation

Szende A, Janssen B, Cabases J, editors. Self-Reported Population Health: An International Perspective based on EQ-5D [Internet]. Dordrecht (NL): Springer; 2014. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK500356/ — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	13-item Sense of Coherence Scale	The 13-item Sense of Coherence Scale is a 13 item, 7-point Likert scale that measures PWP's sense of coherence. Its score ranges from 13-91, with a higher score representing a higher sense of coherence.	[Time Frame: Baseline; 8 weeks; 12 weeks]
Secondary	UCLA three-item loneliness scale	The UCLA three-item loneliness scale is a 3 item, 3-point Likert scale that measures PWP's perceived loneliness. Its score ranges from 3-9, with a higher score indicating a more lonely sensation.	[Time Frame: Baseline; 8 weeks; 12 weeks]
Secondary	Parkinson's Disease Questionnaire (PDQ-8)	Parkinson's Disease Questionnaire (PDQ-8) is an 8 item, 5-point Likert scale commonly adopted to measure PWP's quality of life. The higher summative score indicates a lower quality of life experienced.	[Time Frame: Baseline; 8 weeks; 12 weeks]
Secondary	EuroQol- 5 dimension- 5 level	EuroQol- 5 dimension- 5 level utilized a visual analogue scale from 1-100 and 5 descriptive statements to explore an individual's quality of life. This scale is adopted to validate the newly translated PDQ-8	[Time Frame: Baseline]
Secondary	Mental Health Continuum Short Form	The Mental Health Continuum Short Form is a 14 item, 6-point Likert scale measuring PWP's psychosocial well-being. Its score ranges from 0-70, with a higher score indicating higher psychosocial well-being.	[Time Frame: Baseline; 8 weeks; 12 weeks]
Secondary	Brief Resilient Coping Scale	The Brief Resilient Coping Scale is a 4 item, 5-point Likert scale measuring an individual's coping. Its score ranges from 4-20, with a higher score indicating better coping.	[Time Frame: Baseline; 8 weeks; 12 weeks]
Secondary	Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) is a professional administrated assessment to evaluate an individual's cognitive functioning. This scale will be first administered to screen out PWP with dementia. Its score ranges from 0-30, with a higher score representing higher cognitive functioning.	[Time Frame: Screening; 8 weeks; 12 weeks]
Secondary	System Usability Scale	System Usability Scale is a 10 item,5-point Likert scale that assess the usability of the implemented intervention. Its score ranges from 0-100, with a higher score indicates a higher usability	[Time Frame: 8 weeks]
Secondary	Self-report VIPA usage	PWP will report self-report VIPA usage across the intervention period. A logbook will be provided to PWP to log down their daily usage.	[Time Frame: 8 weeks]